Mesalamine

Product NDC
72162-1804
11-digit product format
721621804
Labeler code
72162
Product ID
72162-1804_f9f95283-e509-42a4-bcdf-f471c0bac950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Bryant Ranch Prepack
Application
ANDA207448
Marketing category
ANDA
Marketing start
2019-06-05
Marketing end
2026-10-31
Substance
MESALAMINE
Active strength
1000 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4Q81I59GXCMESALAMINE89-57-6MESALAMINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72162-1804-1721621804015 PACKAGE in 1 CARTON (72162-1804-1) / 6 SUPPOSITORY in 1 PACKAGE5 package2019-06-052026-10-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Mesalamine - Bryant Ranch PrepackBryant Ranch Prepack2024-11-01HUMAN PRESCRIPTION DRUG LABEL101